Trial Outcomes & Findings for Effects of a Pectoralis Minor Muscle Stretching Protocol (NCT NCT01956240)
NCT ID: NCT01956240
Last Updated: 2015-05-19
Results Overview
The change of the pectoralis minor muscle will be evaluated with a tape measure and electromagnetic device. The length of the muscle will be recorded in centimeters.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
97 participants
Primary outcome timeframe
6 weeks after stretching
Results posted on
2015-05-19
Participant Flow
Fliers posted in the local university setting and community were used to recruit symptomatic individuals, between february of 2012 and January of 2014. Asymptomatic individuals were recruited through personal contacts of the investigators.
If participants did not come back to second evaluation, they were not assignments to groups.
Participant milestones
| Measure |
Asymptomatic Subjects
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
Subjects With Shoulder Pain
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
49
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
23
|
24
|
Reasons for withdrawal
| Measure |
Asymptomatic Subjects
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
Subjects With Shoulder Pain
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
20
|
|
Overall Study
Adverse Event
|
17
|
4
|
Baseline Characteristics
Effects of a Pectoralis Minor Muscle Stretching Protocol
Baseline characteristics by cohort
| Measure |
Asymptomatic Subjects
n=48 Participants
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
Subjects With Shoulder Pain
n=49 Participants
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
48 participants
n=5 Participants
|
49 participants
n=7 Participants
|
97 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after stretchingThe change of the pectoralis minor muscle will be evaluated with a tape measure and electromagnetic device. The length of the muscle will be recorded in centimeters.
Outcome measures
| Measure |
Asymptomatic Subjects
n=48 Participants
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
Subjects With Shoulder Pain
n=49 Participants
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
|---|---|---|
|
Pectoralis Minor Length After Pectoralis Minor Stretching Protocol
|
16.38 centimeters
Standard Deviation 1.46
|
16.87 centimeters
Standard Deviation 1.90
|
SECONDARY outcome
Timeframe: 6 weeks of stretchingThe scapular kinematics will be evaluated with electromagnetic device. The changes in the scapular kinematics will be described in degrees.
Outcome measures
| Measure |
Asymptomatic Subjects
n=25 Participants
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
Subjects With Shoulder Pain
n=25 Participants
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
|---|---|---|
|
Scapular Kinematics After Pectoralis Minor Stretching Protocol
|
30 degree
Standard Deviation 5
|
40 degree
Standard Deviation 5
|
Adverse Events
Asymptomatic Subjects
Serious events: 23 serious events
Other events: 15 other events
Deaths: 0 deaths
Subjects With Shoulder Pain
Serious events: 24 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Asymptomatic Subjects
n=48 participants at risk
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
Subjects With Shoulder Pain
n=49 participants at risk
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
|---|---|---|
|
Social circumstances
Desistance
|
47.9%
23/48
|
49.0%
24/49
|
Other adverse events
| Measure |
Asymptomatic Subjects
n=48 participants at risk
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
Subjects With Shoulder Pain
n=49 participants at risk
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
No shortened pectoralis minor
|
31.2%
15/48
|
14.3%
7/49
|
Additional Information
Ms Dayana Patricia Rosa
Methodist University of Piracicaba
Phone: +55 16 3306-6696
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place